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NCT Number: NCT04817163

Implementation of CBT-I in Cancer Clinics

Insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. When untreated, which is the rule rather than the exception, insomnia often becomes chronic. Chronic insomnia is associated with numerous negative consequences (e.g., increased risk for psychological disorders, health care costs). A large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in cancer patients, but CBT-I is still not offered routinely in cancer clinics. Self-administered CBT-I (e.g., video-based intervention) has been developed to increase patients' access to this treatment. However, results of clinical trials have suggested that these minimal treatments would be better used as a first step of a stepped care model. In stepped care, patients receive only the level of intervention they need. Generally, the entry level is a minimal, less costly, intervention (e.g., self-help intervention) followed by a more intensive form of treatment if needed (if the patient is still symptomatic). The investigators have recently assessed the efficacy of a stepped care model to administer CBT-I in cancer patients, which includes a web-based CBT-I (called Insomnet) followed by up to 3 sessions with a psychotherapist if the patient is still symptomatic. Results of this study suggest that this model of care is non-inferior to a standard face-to-face treatment (Savard, Ivers, et al., in revision), while being more cost-effective. A stepped care CBT-I could therefore be offered in routine cancer care clinics.

This project will assess the feasibility and effectiveness of implementing a stepped care CBT-I in real-world cancer clinics, using a non-randomized stepped wedge design to compare the effects of our program (active phase) with a passive phase. The program is called Insomnia in Patients with Cancer - Personalized Treatment (IMPACT). The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Neoplasms Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche de L'Hôtel-Dieu de Québec

Québec, G1R 2J6, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • have received a diagnosis of non-metastatic cancer (any type)
  • to be aged 18 years and older
  • to be readily able to read and understand French or English
  • having the minimum cognitive abilities to read, understand and memorize information
  • having access to Internet

Exclusion criteria

  • having a psychological comorbidity needing clinical attention (e.g., major depressive disorder)
  • having severe cognitive impairments (e.g., diagnosis of Parkinson's disease, dementia)
  • having insomnia due to a temporary condition (e.g., acute pain, short-term medication side effects, environmental factors)

Treatment and study plan

Web-based cognitive-behavioral therapy for insomnia (CBT-I)

Behavioral

Each week, the patients first have to read written information on the website (www.insomnet.ca), and then watch a video capsule (duration between 5 and 20 min each). Patients complete their daily sleep diary electronically on the website and the content is interactive. It includes the sending of automated emails to remind participants to complete the treatment tasks and encourage adherence, provision of tailored feedback (e.g., texts, charts) based on the information that they provide in their sleep diary, as well as quizzes with automated correction to reinforce patients' understanding of the content.

Other names: Self-administered

Professionally-administered booster face-to-face CBT-I sessions

Behavioral

Patients who obtain an ISI score of 8 and more after completing the web-based CBT-I are "stepped up" and offered to receive up to three 50-min booster sessions of CBT-I offered individually by a psychologist (if needed). Remitted patients (good sleepers; ISI score lower than 8) will receive no further treatment.

Primary outcomes

  1. Implementation (organizational) measures

    Time frame: Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months

    Referral, enrolment and completion rates to the stepped care CBT-I in each clinical setting.

  2. 1) Change in Insomnia Severity Index Scores

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change in Insomnia Severity Index Scores from pre- to post-intervention. The ISI is a 7-item questionnaire designed to evaluate insomnia severity. A score greater than or equal to 8 indicates the presence of insomnia symptoms.

  3. 2) Change in sleep efficiency (SE)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change in daily sleep diary parameters from pre- to post-intervention: Change in sleep efficiency (SE) index (%) = Total sleep time/total time spent in bed X 100.

  4. 3) Change in sleep onset latency (SOL)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change in daily sleep diary parameters from pre- to post-intervention: Change in sleep onset latency (SOL) = Time to sleep after lights out.

  5. 4) Change in wake after sleep onset (WASO)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change in daily sleep diary parameters from pre- to post-intervention: Change in wake after sleep onset (WASO) = Summation of nocturnal awakenings.

  6. 5) Change in total wake time (TWT)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change in daily sleep diary parameters from pre- to post-intervention: Change in total wake time (TWT) = Summation of SOL, WASO, and early morning awakening.

  7. 6) Change in total sleep time (TST)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change in daily sleep diary parameters from pre- to post-intervention: Change in total sleep time (TST) = Time in bed minus total wake time.

  8. 7) Hospital Anxiety and Depression Scale (HADS)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change scores from pre to post-intervention: Hospital Anxiety and Depression Scale (HADS): A 14-item questionnaire comprising 7 items assessing depression and 7 items assessing anxiety. Scores obtained for each subscale range from 0 to 21.

  9. 8) Fatigue Symptom Inventory (FSI)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change scores from pre to post-intervention: Fatigue Symptom Inventory (FSI): A 14-item questionnaire measuring perceived fatigue. Each item is rated on an 11-point Likert scale, ranging from 0 to 10. A higher score indicates a higher level of fatigue or interference or a longer duration of fatigue.

  10. 9) The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change scores from pre to post-intervention: The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30): A 30-item questionnaire. Scores are transformed to give a score ranging from 0 to 100.

  11. 10) Satisfaction with Life Scale (SWLS)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Change scores from pre to post-intervention: Satisfaction with Life Scale (SWLS): A 5-item questionnaire (Likert scale from 1 to 7) designed to measure global cognitive judgments of satisfaction with one's life.

  12. 1) Psychologists' adherence to the protocol

    Time frame: Throughout the active phase, up to 20 months

    Psychologists' self-assessed adherence to the CBT-I protocol (%)

  13. 2) Psychologists' perceived self-efficiency

    Time frame: Throughout the active phase, up to 20 months

    Psychologists' perceived self-efficiency in using CBT-I protocol (%)

Secondary outcomes

  1. 1) Demographic characteristics

    Time frame: Pre-treatment and post-treatment (6-8 weeks later) for patient; Through study completion (an average of 24 months) for clinicians

    Clinicians and patients' demographics (e.g., age, sex)

  2. 2) Evidence-Based Practice Attitudes Scale (EBPAS)

    Time frame: Through study completion, an average of 24 months

    Administrators' and clinicians' attitude towards empirically-based treatments (Evidence-Based Practice Attitudes Scale (EBPAS; 15 items)): Scores obtained range from 0 to 60.

  3. 3) Workplace Stress Scale (WSS)

    Time frame: Through study completion, an average of 24 months

    Stress at work (Workplace Stress Scale (WSS; 8 items)): Scores obtained range from 8 to 40.

  4. 4) Organizational Readiness for Implementing Change (ORIC)

    Time frame: Through study completion, an average of 24 months

    Attitude towards change (Organizational Readiness for Implementing Change (ORIC; 12 items)): Participants rated the hospital's readiness for implementation on 12 items using a 5-point ordinal scale that ranged from "disagree" (1) to "agree" (5).

  5. 5) Clinicians expertise

    Time frame: Through study completion, an average of 24 months

    Clinicians' CBT expertise (number of years of experience with CBT)

  6. 6) Internet Evaluation and Utility Questionnaire (IEUQ)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Patients' familiarity with the Internet (Internet Evaluation and Utility Questionnaire (IEUQ; 15 items)): Patients respond to the questions on a 5-point likert scale from "not at all" (0) to "very" (4), with 2 open-ended items asking patients to identify "most helpful" and "least helpful" parts of the web program.

  7. 7) Brief Health Literacy Screening Tool (BRIEF)

    Time frame: Pre-treatment and post-treatment (6-8 weeks later)

    Health literacy (Brief Health Literacy Screening Tool (BRIEF; 4 items)): Each item ranges from 1 to 5 and total scores range from 4 to 20.

  8. Possible moderating treatment effect

    Time frame: Pre-treatment (at recruitment)

    Possible moderating treatment effect by some of the participants' characteristics (e.g., age, sex, cancer site).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

  • Canadian Cancer Society (CCS)
  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Implementation of a Stepped Care Cognitive-Behavioral Therapy for Insomnia in Routine Cancer Care

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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